Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

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Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]

To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains Mean Urinary Free Cortisol (mUFC) ≤ 1.0 X Upper Limit of Normal (ULN) at month 7 regardless of dose-titration.

Secondary Outcome Measures
:

Proportion of responders in each of the Pasireotide LAR (long acting release) 10 mg and 30 mg doses independently in patients with Cushing's disease after 7 months of treatment who did not up titrate the doses of Pasireotide at month 4. [ Time Frame: 7 months ]

A responder is defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.

Change in mean urinary free cortisol from baseline at every month in the core and every 3 months in extension within the two Pasireotide LAR regimens [ Time Frame: 26 months ]

Proportion of responders in the two Pasireotide LAR regimens at every month in the core and every 3 months in the extension phases [ Time Frame: 26 months ]

Proportion of responders in the two Pasireotide LAR regimens as measured by controlled and partially controlled mUFC(mean urinary free cortisol) combined responders at every month in the core and every 3 months in the extension [ Time Frame: 26 months ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)

For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

Patients who are considered candidates for surgical treatment at the time of study entry

Patients who have received pituitary irradiation within the last ten years prior to visit 1

Patients who have had any previous pasireotide treatment

Patients who have been treated with mitotane during the last 6 months prior to Visit 1

Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c >8%

Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF >470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval

Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com